1 year contract validation engineer ($4K to $5K) - Medical Device

Recruit Express Pte Ltd| Date Posted: 16-Jan-2021
EA Licence No: 99C4599|EA Personal Registration No: R1333338
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Job Nature:
Contract
Position Level:
Experienced
Qualification:
Bachelor's / Honours

Job Description

  • Provide guidance on planning and execution of validation projects for manufacturing equipment, processes and facilities
  • Lead development of validation strategies and guide validation planning
  • Work with cross-functional teams on preparation and execution of validation activities
  • Review validation protocols and reports; provide QA support
  • Manage IFC quality engineering and lead / participate in investigation and implementation of corrective and preventive actions for customer complaints and non-conforming products, and follow up on proper closure with verification of effectiveness.
  • Collaborate with HQ, Tech Support and cross functional teams on customer complaints and respond to inquiries as needed.
  • Ensure proper documentation of customer feedback and analyse failure trends to identify improvement actions.
  • Manage records and tracking of reports from quality sub-systems such as Non-Conformance Request (NCR), Corrective Action (CA), and Preventive Action (PA) and ensure timely closure.
  • Analyze quality monitoring data, trend performance, and prepare reports to communicate results of quality assurance activities.

Minimum Qualifications

  • Min Bachelor’s Degree in Engineering, Science, Biotechnology or related fields.
  • 5+ years’ experience in validation and QA in medical device manufacturing.
  • Thorough knowledge and understanding of ISO 13485 and cGMP/QSR, validation principles, and applicable regulations related to validation principles.

Interested candidates, please forward your resume to [Click Here to Email Your Resume] 

Consultant: Huang Jingsheng Kevyn (R1333338) 

Recruit Express Pte Ltd (99C4599) 

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Recruit Express Pte Ltd